(75 days)
The intended use of Redyrob is as a vacuum source / waste container utilized for post operative wound drainage. The indications for use for the device are to drain blood and secretions from wounds and body cavities for hematoma and surtma prophylaxes and for the removal of serosanguineous fluid and other harmful liquids.
REDYROB ® is a vacuum source/waste container utilized for postoperative wound drainage.
The provided text describes a 510(k) submission for the REDYROB® Closed Wound Drainage System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study establishing new performance metrics or acceptance criteria as one might find for a novel, high-risk device.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as they are not typically part of a 510(k) for a Class I device of this nature. The "acceptance criteria" here primarily refer to the product meeting its design specifications and demonstrating suitability through material testing and physical testing, rather than clinical performance metrics.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Safety | Biocompatibility in accordance with ISO Standard 10993. | Materials "have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product." |
| Product Release | Meet all required release specifications (physical testing, visual examination). | "All finished products are tested and must meet all required release specifications before distribution." "The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product)." "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." |
| Substantial Equivalence | Similar intended use as predicate device (Varidyne Model 250 Suction Drainage System). No new issues of safety or effectiveness. | REDYROB® "is similar in intended use to the Varidyne Model 250 Suction Drainage System manufactured by Surgidyne. There are no new issues of safety or effectiveness raised by REDYROB® Closed Wound Drainage System." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified for material or physical testing. The context implies routine quality control testing of manufactured units, which would involve a representative sample size based on manufacturing volumes and statistical sampling plans, but the specific numbers are not provided in this regulatory summary.
- Data Provenance: Not explicitly stated regarding country of origin for testing data. The testing is described as occurring internally by B. Braun Medical, Inc. (USA-based company). The testing is retrospective, as it's part of post-manufacturing quality control and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of this 510(k) summary. The "ground truth" for the device's technical performance is based on internal quality control standards and specifications, not expert clinical diagnosis or interpretation.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for a diagnostic device. Here, the "truth" is whether a manufactured unit meets its engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs. without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic device, nor is it a device that involves human readers or interpretation of results in that sense. It is a physical medical device (a wound drainage system).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The REDYROB® is a physical device, not an algorithm.
7. The Type of Ground Truth Used:
- For material safety, the ground truth is established by ISO Standard 10993 requirements for biocompatibility.
- For product performance, the ground truth is established by product design specifications, quality control test procedure documents, and established testing parameters. This is based on engineering and manufacturing standards.
- For substantial equivalence, the ground truth is the performance and safety profile of the legally marketed predicate device (Varidyne Model 250 Suction Drainage System).
8. The Sample Size for the Training Set:
- Not applicable. This document does not describe the development of a predictive model or algorithm that would require a training set. The device is a physically manufactured product.
9. How the Ground Truth for the Training Set was Established:
- Not applicable for the same reason as above. There is no training set for this type of device.
§ 878.4680 Nonpowered, single patient, portable suction apparatus.
(a)
Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.